Improved progression-free, but not overall survival with fludarabine plus cyclophosphamide in patients with chronic lymphocytic leukemia
Researchers in the United Kingdom have reported increased progression-free, but not overall survival with fludarabine plus cyclophosphamide in patients with chronic lymphocytic leukemia (CLL), in a study presented in The Lancet this week.
In this study, 777 patients with CLL received fludarabine plus cyclophosphamide, fludarabine alone, or chlorambucil alone. There was no significant difference in overall survival between all three treatments groups. Complete and overall response rates (CR and ORR) were significantly higher with fludarabine plus cyclophosphamide than with fludarabine (CR: 38% vs 15%, respectively; ORR: 94% vs 80%, respectively; p<0•0001), which were significantly higher than with chlorambucil (CR: 7%; ORR: 72%; p=0•006 and 0•04, respectively). Progression-free survival was significantly higher with fludarabine plus cyclophosphamide than with fludarabine or chlorambucil (36% vs 10% vs 10%, respectively; p<0•00005).
A meta-analysis of data from this study and of two other Phase III trials showed a consistent benefit with fludarabine plus cyclophosphamide in terms of progression-free survival.
Author’s conclusions: fludarabine plus cyclophosphamide should now become the standard treatment for chronic lymphocytic leukaemia and the basis for new protocols that incorporate monoclonal antibodies.
Source: http://www.thelancet.com/journals/lancet/article/PIIS0140673607611258/abstract
Sunday, July 22, 2007
Saturday, July 21, 2007
AZD2171 (RECENTIN™) shows promising anti-tumour activity in advanced solid tumours
Researchers have reported that AZD2171 (RECENTIN™; AstraZeneca) shows promising anti-tumour activity and is generally well-tolerated in various advanced solid tumours, in a study reported in the Journal of Clinical Oncology this week.
AZD2171 is a highly potent oral selective inhibitor of vascular endothelial growth factor (VEGF) signaling, thereby inhibiting tumour angiogenesis.
This Phase I study consisted of two parts. In part A, 36 patients with advanced solid tumours and liver metastases received al AZD2171 0.5 to 60 mg, once daily to identify the maximum tolerated dose. In part B, 36 patients with and 11 patients without liver metastases received oral AZD2171 (20, 30 or 45 mg). Patients continued to receive treatment until tumour progression or dose-limiting toxicity occurred.
Eighty-three patients received AZD2171, which was generally well-tolerated up to a dose of 45 mg/day. Most frequently reported adverse events included diarrhea, dysphonia and hypertension, and the most common dose-limiting toxicity was hypertension in 7/83 (8.4%) patients at doses ≥ 20 mg.
Maximum peak drug concentrations after a single dose of AZD2171 occurred between 1 and 8 hours post-AZD2171 administration with a mean half-life of 22 hours.
Promising anti-tumour activity was observed with two (2.4%) patients achieving confirmed partial responses and 22 (26.5) patients achieving stable disease.
Author’s conclusions: Once-daily oral AZD2171 at doses of ≤45 mg was generally well tolerated and associated with encouraging anti-tumour activity in patients with a broad range of advanced solid tumours.
Additional information: a number of clinical trials of AZD2171 as a single-agent or in combination with other agents in various solid tumours are ongoing (follow link below)
http://www.astrazenecaclinicaltrials.com/article/516060.aspx
Source: http://jco.ascopubs.org/cgi/content/abstract/25/21/3045
Researchers have reported that AZD2171 (RECENTIN™; AstraZeneca) shows promising anti-tumour activity and is generally well-tolerated in various advanced solid tumours, in a study reported in the Journal of Clinical Oncology this week.
AZD2171 is a highly potent oral selective inhibitor of vascular endothelial growth factor (VEGF) signaling, thereby inhibiting tumour angiogenesis.
This Phase I study consisted of two parts. In part A, 36 patients with advanced solid tumours and liver metastases received al AZD2171 0.5 to 60 mg, once daily to identify the maximum tolerated dose. In part B, 36 patients with and 11 patients without liver metastases received oral AZD2171 (20, 30 or 45 mg). Patients continued to receive treatment until tumour progression or dose-limiting toxicity occurred.
Eighty-three patients received AZD2171, which was generally well-tolerated up to a dose of 45 mg/day. Most frequently reported adverse events included diarrhea, dysphonia and hypertension, and the most common dose-limiting toxicity was hypertension in 7/83 (8.4%) patients at doses ≥ 20 mg.
Maximum peak drug concentrations after a single dose of AZD2171 occurred between 1 and 8 hours post-AZD2171 administration with a mean half-life of 22 hours.
Promising anti-tumour activity was observed with two (2.4%) patients achieving confirmed partial responses and 22 (26.5) patients achieving stable disease.
Author’s conclusions: Once-daily oral AZD2171 at doses of ≤45 mg was generally well tolerated and associated with encouraging anti-tumour activity in patients with a broad range of advanced solid tumours.
Additional information: a number of clinical trials of AZD2171 as a single-agent or in combination with other agents in various solid tumours are ongoing (follow link below)
http://www.astrazenecaclinicaltrials.com/article/516060.aspx
Source: http://jco.ascopubs.org/cgi/content/abstract/25/21/3045
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